Senior Regulatory Affairs Associate

At Alcon were passionate about enhancing sight and helping people see brilliantly. With more than 25000 associates we innovate fearlessly champion progress and act swiftly to impact global eye health. We foster an inclusive culture recognizing your contributions and offering opportunities to grow your career like never before. Together we make a difference in the lives of our patients and customers. Are you ready to join us

This role is part of Alcons Quality & Regulatory Affairs function a team that ensures our products are in compliance with global local and internal regulations and meet the strictest standards of quality as we help people see brilliantly. The Sr. Associate Regulatory Affairs Strategy (Professional Path) reporting to the Senior Manager of Regulatory Affairs (LLSI) is primarily responsible for coordinating regulatory compliance for Alcons product portfolio managing local initiatives and supporting business requests for product and regulatory information. You will also participate in cross-functional teams for risk management and produce compliance metrics. Occasionally you will represent the Regulatory Affairs Manager when requested.

In this role a typical day will include:

• Operational support / execution tasks associated with LCM work
  • Working with Reg. Ops. to complete user fee requests
  • Data requests to R&D for tender applications one-off requests for country-specific technical information maintenance of project status master slide deck for regional RA calls drafting (not signing) explanation letters and other administrative requirements for HA queries
• Perform specialized tasks and conduct independent research within the Regulatory Affairs Strategy team to optimize outcomes and contribute to project goals
• Coordinate product submissions renewals and updates by liaising with plants agents and authorities to ensure timely submissions and approvals
• Oversee promotional material approval for Alcon ME/KSA portfolio ensuring ethical conduct and compliance with laws codes and regulations
• Provide regulatory strategies for new product introductions and changes maintaining compliance to drive competitive advantage
• Support medical device and/or pharmaceutical products ensuring adherence to relevant regulations
• Adhere to Good Practice (GxP) regulations by following Standard Operating Procedures (SOPs) maintaining documentation ensuring quality control and completing required training
• ROW submissions for new projects with supervision
• Assistance with LCM work with supervision
  • Change assessments / RIARs
  • PPRR work registration renewals TF maintenance etc.
• Operational support / execution tasks associated with LCM work
  • Working with Reg. Ops. to complete user fee requests
  • Data requests to R&D for tender applications one-off requests for country-specific technical information maintenance of project status master slide deck for regional RA calls drafting (not signing) explanation letters and other administrative requirements for HA queries

WHAT YOULL BRING TO ALCON:

• Bachelors Degree or Equivalent years of directly related experience (or high school 10 yrs; Assoc.16yrs; M.S.0 yrs) The ability to fluently read write understand and communicate in English
• 2 Years of Relevant Experience
• 1 Years of Demonstrated Leadership
• Location: Onsite Lake Forest CA
• Travel Requirements: 0 10%
• Relocation Assistance: Not Available
• Sponsorship Available: Not Available

HOW YOU CAN THRIVE AT ALCON:

• Collaborate with teammates to share standard processes and learnings as work evolves!
• See your career like never before with focused growth and development opportunities
• Join Alcons mission to provide outstanding innovative products and solutions to improve sight improve lives and grow your career!
• Alcon provides robust benefits package including health life retirement flexible time off for exempt associates PTO for hourly associates and much more!

Alcon Careers

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Compensation and Benefits

Alcons Total Rewards programs are designed to align incentives with business objectives support our values and deliver longterm value. Our compensation approach includes a combination of fixed and variable pay with shortterm and longterm incentive opportunities for eligible roles. Our benefits offerings are designed to support associates and their families across key life events including programs that promote health and wellbeing provide financial security and support retirement planning.

The salary range posted represents the anticipated hiring range for this role. Actual compensation may vary based on factors such as experience skills location and internal equity and may fall outside the posted range.

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Alcon is an Equal Opportunity Employer and participates in E-Verify. Alcon takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment hiring training promotion or other employment practices for reasons of race color religion gender national origin age sexual orientation gender identity marital or veteran status disability or any other legally protected status. Alcon is also committed to working with and providing reasonable accommodation to individuals with disabilities. If because of a medical condition or disability you need a reasonable accommodation for any part of the application process or in order to perform the essential functions of a position please send an email to and let us know the nature of your request and your contact information.